BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2931120 · Received January 28, 2013

    Report

    Report Number
    2531779-2013-01218
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    January 8, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(4) -DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX INDICATED THAT THE LAST BASAL DELIVERY OCCURRED ON (B)(6) 2013 AT 8:47PM. SEVERAL LOSS OF PRIME WARNINGS WERE OBSERVED DURING THE REPORTED EVENT PERIOD. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP POWERED ON NORMALLY AND PRIMED SUCCESSFULLY. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES AND NO ALARMS OCCURRING. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. THE FORCE SENSOR CALIBRATION WAS FOUND TO BE WITHIN SPECIFICATION. THERE WAS NO DAMAGE OBSERVED TO THE FORCE SENSOR OR THE POWER FLEX. THERE WAS NO DEFECT FOUND ON INVESTIGATION; THE COMPLAINT COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013, REPORTING THAT THE PUMP EMITTED MULTIPLE LOSS OF PRIMES. THE PATIENT STATED THAT THEIR BLOOD GLUCOSE (BG) READ HIGH ON THE METER WITH KETONES AND NAUSEA AND VOMITING. THE PATIENT STATED THEY PRIMED AND TREATED UNTIL THE BG WAS IN CONTROL. THE PATIENT CONFIRMED THAT THERE WAS NO SELF REBOOT OF THE PUMP AND NO KNOWN TRAUMA TO THE PUMP. THE PATIENT STATED THAT SHE USED CARTRIDGES FROM TWO DIFFERENT BOXES. SHE IS CURRENTLY USING A CARTRIDGE FROM HER HEALTHCARE PROFESSIONAL'S OFFICE. THIS REPORT IS BEING MADE DUE TO THE PATIENT'S HYPERGLYCEMIC EVENT WHILE ON INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37536 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Life Threatening